Clinical trial · Interventional
Extracorporal Photopheresis Pilot Study
Allogenic Hematopoietic Stem Cell Transplantation (HSCT) From a Genoidentical Donor After a Reduced Intensity Conditioning Transplantation (RICT) Followed by an Early Preventive Treatment (Day 21) With Extracorporal Photopheresis After Transplantation.
NCT00930566CI-TRIAL-00010124ECPunknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
ECP will be given to the patients \[UVAR®XTS TM Therakos system, Johnson \& Johnson\] according to the following schedule: Starting at day 21 after transplant, if hematologic recovery allowed it: 2 ECP per week the first 2 weeks, and 1 ECP per week during 1 month. Total = 8 ECP after transplantation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extracoporal Photopheresis (ECP) | Procedure | — | UNRESOLVED |
| methoxsalen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Extracorporal Photopheresis
- interventionNames
- Drug: methoxsalen
- Procedure: Extracoporal Photopheresis (ECP)
Primary outcomes (1)
- measure
- Evaluation of the toxicity at Day 100 (NCI/NIH Common Toxicity Criteria) of Extracorporal Photopheresis (ECP) administered for Graft-versus-host-disease (GVHD) prophylaxis and introduced early (Day 21) after an HSCT from a genoidentical donor.
- timeFrame
- Day 100
- description
- All types of toxicity will be assessed and graded according to NCI/NIH Common Toxicity Criteria
Secondary outcomes (9)
- measure
- Efficacy: decrease in incidence of acute GVHD and chronic GVHD
- timeFrame
- during 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥ 18 years and \< or = 65 years with an hematological malignancy indicated for an allogeneic transplantation after reduced intensity conditioning : * due to the age : for patients between 55 and 65 years. * or for patients between 18 and 55 years of age presenting a risk of increased toxicity for myeloablative conditioning (cardiac, renal or pulmonary pathology) * CML and MPS in blastic phase achieving CR, * MM stage II or III, relapse after autologous transplant, achieving a response ≥ 30% or on first line if high risk, * NHL in 2nd CR, PR after chemotherapy or autologous transplant, chemo-sensible. * CLL in 2nd CR, PR after chemotherapy or autologous transplant, chemo-sensible. * AML in 2nd CR or in first line for high risk criteria, secondary AML. In AML, high risk criteria are defined by : LAM 7, leukocytes\>30000/mm3, cytogenetic abnormalities: t(6,9); 11q23, 17p, 11q, 20q, 21q, -5, del(5q), -7/del7q, del 9q and inv 3q, * ALL in 2nd CR or in first line for high risk criteria defined by cytogenetic abnormalities: 11q23, t(9,22); t(1,19); t(4,11). * MDS patients without prior chemotherapy * HLA identical sibling donor * Performans status \< or = 2 * Patients member of a social security company Exclusion Criteria: * Age \< 18 years or \> 65 years * Pregnant or lactating females * Known HIV positivity * Active infectious hepatitis, type A, B or C * Performance status \> 2 according to WHO * Left ventricular ejection fraction \< 40% and Alveolus-capillary diffusion \< 50% * Uncontrollable hypertension with medical therapy * Creatinine clearance \< 60 ml/min * Hypersensitivity or allergy to psoralen (methoxsalen) * Disease associated with a photosensitivity * Hypersensitivity or allergy to both heparin and citrate products * Contra-indication to Busulfan, Fludarabine, SAT or methotrexate * Hypersensitivity to ciclosporine, mycophenolate mofetil or mycophenolic acid
References
Publications (0)
Data not yet available
No reference posted for this study.